Quality Validation Engineer

Avantor is looking for a Quality Validation Engineer to join our Quality team and make an impact through validation governance, regulatory compliance, ownership of validated system lifecycles, and independent review and approval of validation deliverables.

This role is hybrid out of our Devens, MA site.

What we're looking for

• Education: Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related technical discipline; or a combination of education and experience that would provide the required knowledge, skills, and abilities
• Experience: 3-7+ years of validation experience in a regulated manufacturing environment with demonstrated CSV experience
  • Demonstrated knowledge of risk-based validation and quality systems (change control, deviation/CAPA, document control, training)
  • Working knowledge of applicable regulations/standards (e.g., ISO 9001, cGMP/21 CFR 210/211; EU GMP Annex 11, GAMP 5)
• Preferred Qualifications:
  • Experience supporting electronic batch record (EBR) systems
  • Relevant Engineering and/or Quality certifications
  • Experience with ERP systems
  • Bioprocessing, single-use, or medical device industry background

How you will thrive and create an impact

The Engineer leads and supports validation activities to ensure compliance, product quality, data integrity, and maintenance of a sustained validated state. The role has primary responsibility for Computer System Validation (CSV) of Quality and GxP computerized systems and provides Quality validation governance for controlled environments (e.g., ISO cleanrooms and supporting utilities). The role partners cross-functionally to support new product introductions (NPI), facility expansions, and process or system changes by defining validation strategy, coordinating execution with stakeholders, and independently reviewing/approving validation evidence.

• Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS/training, LIMS, ERP, EM systems, quality-related interfaces), including validation planning, risk assessment, User Requirements specifications, traceability, protocol oversight, reporting, release to use, periodic review, and retirement.
• Ensure validated state is maintained through change control impact assessments and deviation assessments, providing validation support and oversight for related system controls and testing activities in partnership with IT and system owners.
• Support Quality validation governance for cleanrooms and controlled environments, including development/maintenance of qualification plans and protocols, review of test data/results (e.g., ISO classification, airflow/pressure relationships, recovery, temperature/humidity mapping, and environmental mapping where applicable), and definition of requalification triggers tied to change control, maintenance, and risk.
• Support NPI, tech transfer, automation implementation, and major change projects by defining risk-based validation strategy and aligning validation deliverables to project stage-gates. Coordinating cross-functional execution.
• Provide independent Quality oversight and approval for production equipment qualification and process validation activities led by Operations/Engineering.
• Serve as site Validation/CSV subject matter expert for internal/external audits and inspections and support inspection readiness, gap assessments, and responses to validation/CSV observations.
• Track validation commitments, schedules, and metrics and communicate status, risks, and resource needs to Quality leadership and project teams.

KNOWLEDGE SKILLS AND ABILITIES

• Proven ability to lead validation efforts and influence crossfunctional teams, even without direct reports.
• Ability to author clear, audit-ready validation documentation including plans, risk assessments, URS/specifications, traceability matrices, protocols, and reports.
• Strong understanding of CSV concepts, SDLC, IT control areas (access control, backup/restore, patching, cybersecurity, disaster recovery) and how they support data integrity and validated state.
• Understanding of cleanroom concepts (airflow/pressure cascades, particulate control, recovery, HVAC performance, environmental monitoring interfaces) and the linkage to product and quality risk.
• Project management skills: planning, scheduling, stakeholder management, risk communication, and delivering to timelines with minimal supervision.
• Strong analytical/problem-solving skills and the ability to make sound, risk-based decisions and impact assessments.
• Excellent communication and influencing skills across Quality, Operations, Engineering/Facilities, IT, and suppliers/vendors.
• Ability to work effectively in a matrix environment and to coach/train others on validation expectations.

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT

• Typically works in an office environment with adequate lighting and ventilation, and a normal range of temperature and noise level.
• The position involves a steady workload, balancing multiple priorities and adhering to frequent deadlines in a fast-paced environment.
• Some physical effort is required. Work may require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 25 lbs.
• Some travel may be required.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with a job.

#LI-Hybrid

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.comand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

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3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.